Life-saving medical equipment is not tested
Medical devices like cardiac implants end up on the market without being tested on people in advance, shows a major review as a number of media houses stand behind the report.
252 journalists and computer specialists from 36 countries stand behind Sunday’s disclosure. Among those who have participated is Aftenposten, which together with 58 other media houses around the world has examined how the powerful implant industry has gone under the government’s radar.
90 per cent not tested
The survey shows, among other things, that 90 per cent of the equipment comes on the European market without being clinically tested on humans. This is evidenced by an email sent from the German to the Danish EU Representation in March 2016.
Instead, the products are approved by referring to similar products that are already on the market, writes the Danish news agency Ritzau.
1.7 million patient injuries and close to 83,000 deaths have been linked to medical devices which may or may not have failed, while nearly 500,000 patients had to get operated to get an implant out of them, Aftenposten writes.
The newspaper points out that the manufacturers of medical equipment belong to a powerful multimillion industry that has rarely been the subject of critical journalism. According to the newspaper, equipment manufacturers will trade NOK 3,600 billion worldwide in 2018. This is three times more than Norway’s total revenues. Growth has been enormous since 2000 when revenues were around NOK 970 billion.
At the same time, the manufacturers themselves are conducting studies on equipment they produce. Neither doctors nor authorities have the opportunity to test them, Aftenposten writes.
In Norway, the authorities do not have an overview of exactly what equipment, such as joint prostheses, pacemakers and silicone implants, are used in this country.
“We do not have our own approval or registration of equipment for use or sale in and to Norway,” says senior counsellor Ingeborg Hagerup-Jenssen in the Norwegian Medicines Agency to Aftenposten.
While it requires years of research and thorough testing to get a new drug approved, the process of medical equipment is far easier.
© NTB scanpix / #Norway Today